A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors
PRIMARY OBJECTIVES:
I. To evaluate progression-free survival (PFS) associated with temozolomide alone or
temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors.
SECONDARY OBJECTIVES:
I. To evaluate response rates (RR) associated with temozolomide alone or temozolomide and
capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors.
II. To evaluate overall survival (OS) associated with temozolomide alone or temozolomide and
capecitabine in patients with advanced pancreatic neuroendocrine tumors.
III. To evaluate the toxicity associated with temozolomide alone or temozolomide and
capecitabine treatment in patients with advanced pancreatic neuroendocrine tumors.
IV. To evaluate the usefulness of methyl guanine methyltransferase (MGMT) status (by
immunohistochemistry [IHC] and promoter methylation) for predicting response in pancreatic
neuroendocrine tumor patients treated with either temozolomide or temozolomide and
capecitabine.
V. To bank radiology images for evaluation of quality, reproducibility, and compliance with
computed tomography (CT) methodology.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5. Treatment
repeats every 28 days for up to 13 courses in the absence of disease progression or
unacceptable toxicity.
ARM B: Patients receive capecitabine PO twice daily (BID) on days 1-14 and temozolomide PO
QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years,
and then every 6 months for 3 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
PFS
There will be two log-rank tests conducted, an interim analysis at 76% information and a final analysis at 100% information (105 PFS events), projected to occur at 3 years from the start of accrual. The overall type I error will be controlled using an O'Brien-Fleming boundary function. If the repeated two-sided 95% confidence interval on the hazard ratio does not contain the target alternative hazard ratio of 0.64, consideration will be given to declaring the study negative and reporting the results.
Up to 5 years
No
Pamela Kunz
Principal Investigator
Eastern Cooperative Oncology Group
United States: Institutional Review Board
E2211
NCT01824875
December 2012
Name | Location |
---|---|
Eastern Cooperative Oncology Group | Boston, Massachusetts 02215 |